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Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers

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Disease Information

Descriptive Information
Brief Title † Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
Official Title † A Phase II, Pilot, Randomized, Open-Label, Single-Center Study to Evaluate Immunogenicity, Safety and Booster Response of 3 Full Intramuscular Doses Versus 3 Half Intramuscular Doses Versus 3 Intradermal Doses Versus 2 Intradermal Doses of PCEC Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine as a Pre-Exposure Regimen in 12 to 18 Months Old Toddlers in Thailand.
Brief Summary This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary Outcome Measure † Rabies virus neutralizing antibody concentrations
Secondary Outcome Measure † Japanese encephalitis virus neutralizing antibody titers
Condition † Rabies Japanese Encephalitis Pre-Exposure Prophylaxis
Intervention † BiologicalThree 1 mL doses of Rabies vaccine and two JE vaccine
Study Arms / Comparison Groups 1 2 3 4 5
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 200
Start Date † August 2002
Completion Date September 2004
Primary Completion Date August 2004
Eligibility Criteria † Inclusion Criteria: - Male and female 12-18 months old toddlers if they - are in good health at time of entry into the study - are available for all the visits scheduled in the study - have been granted a written informed consent, signed by their parents Exclusion Criteria: - a history of rabies immunization - a history of Japanese encephalitis immunization or disease - a significant acute or chronic infectious disease at the time of enrollment - fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment - being under treatment with corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment - administration of any vaccine within the past 14 days before enrollment - known immunodeficiency or an autoimmune disease - history of allergy to eggs, egg products - known hypersensitivity to neomycin, tetracycline, amphotericin-B - planned surgery during the study period - being enrolled in any other investigational trial contemporaneously - the family plans to leave the area of the study site before the end of study period - history of febrile convulsions - history of wheezing
Gender Both
Ages 12 Months - 18 Months
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † Thailand
Administrative Information
NCT ID † NCT00694460
Organization ID M49P2
Secondary IDs ††
Responsible Party
Study Sponsor † Novartis
Collaborators †† Novartis Vaccines
Investigators † Study Chair: Novartis Vaccines, Novartis Vaccines
Information Provided By
Verification Date June 2008
First Received Date † May 30, 2008
Last Updated Date June 9, 2008
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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